A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
- Conditions
- High-risk, non-metastatic castration-resistant prostate cancer (MedDRA: hormonerefractory prostate cancer)MedDRA version: 21.1Level: LLTClassification code 10066489Term: Progression of prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003820-36-DE
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1500
1. Written informed consent (IC) obtained.
2. Males aged = 18 years.
3. Histologically or cytologically confirmed adenocarcinoma of prostate
without neuroendocrine differentiation or small cell features.
4. CRPC is defined as 3 rising PSA levels after the nadir taken at least 1
week apart during ADT. If the patient has a history of antiandrogen use,
the most recent PSA value must be obtained at least 4 weeks after
antiandrogen withdrawal. See Section 6.1.1 of the Protocol for further
details.
5. Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy.
Patients who have not undergone bilateral orchiectomy must continue
GnRH therapy during the study.
6. PSADT of = 10 months and PSA > 2 ng/ml at screening.See Section
6.1.1 of the Protocol for further details.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-
1.
8. Blood counts at screening: haemoglobin = 9.0 g/dl, absolute
neutrophil count = 1500/µl (1.5x10^9/l), platelet count = 100,000/µl
(100x10^9/l ) (patient must not have received any growth factor or
blood transfusion within 7 days of the haematology laboratory obtained
at screening).
9. Screening values of serum alanine aminotransferase (ALT) and
aspartate transaminase (AST) = 2.5 x upper limit of normal (ULN), total
bilirubin = 1.5 x ULN (except patients with a diagnosis of Gilbert's
disease), creatinine = 2.0 x ULN.
10. Sexually active patients, unless surgically sterile, must agree to use
condoms as an effective barrier method and refrain from sperm donation
during the study treatment and for 3 months after the end of the study
treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1200
1. History of metastatic disease at any time or presence of detectable
metastases by blinded central reading within 42 days prior to start of
study treatment. Presence of pelvic lymph nodes < 2 cm in short axis
below the aortic bifurcation is allowed. See Section 6.1.1 of the Protocol
for further details.
2. Symptomatic local-regional disease that requires medical intervention
including moderate/severe urinary obstruction or hydronephrosis due to
prostate cancer.
3. Acute toxicities of prior treatments and procedures not resolved to
grade <=1 or baseline before randomisation.
4. Prior treatment with: second generation AR inhibitors such as
enzalutamide, ARN-509, ODM-201, other investigational AR inhibitors,
CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
oral ketoconazole longer than for 28 days.
5. Use of estrogens or 5-a reductase inhibitors (finasteride, dutasteride)
within 28 days before randomisation and AR inhibitors (bicalutamide,
flutamide, nilutamide, cyproterone acetate) at least 28 days before
screening.
6. Prior chemotherapy or immunotherapy for prostate cancer, except
adjuvant/neoadjuvant treatment completed > 2 years before
randomisation.
7. Use of systemic corticosteroid with dose greater than the equivalent
10 mg of prednisone/day within 28 days before randomisation.
8. Radiation therapy (external beam radiation therapy [EBRT],
brachytherapy, or radiopharmaceuticals) within 12 weeks before
randomisation.
9. Severe or uncontrolled concurrent disease, infection or co-morbidity
that, in the opinion of the investigator, would make the patient
inappropriate for enrolment.
10. Treatment with an osteoclast-targeted therapy (bisphosphonate or
denosumab) to prevent skeletal-related events within 12 weeks before
randomisation. Patients receiving osteoclast-targeted therapy to prevent
bone loss at a dose and schedule indicated for osteoporosis may
continue treatment at the same dose and schedule.
11. Known hypersensitivity to the study treatment or any of its
ingredients.
12. Major surgery within 28 days before randomisation.
13. Any of the following within 6 months before randomisation: stroke,
myocardial infarction, severe/unstable angina pectoris,
coronary/peripheral artery bypass graft; congestive heart failure New
York Heart Association (NYHA) Class III or IV.
14. Uncontrolled hypertension as indicated by a systolic BP >=160
mmHg or diastolic BP >=100 mmHg at screening.
15. Prior malignancy. Adequately treated basal cell or squamous cell
carcinoma of skin or superficial bladder cancer that has not spread
behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as
well as any other cancer for which chemotherapy has been completed
>=5 years ago and from which the patient has been disease-free.
16. Gastrointestinal disorder or procedure which expects to interfere
significantly with absorption of study treatment.
17. Active viral hepatitis, active human immunodeficiency virus (HIV) or
chronic liver disease.
18. Treatment with any investigational drug within 28 days before
randomisation.
19. Any condition that in the opinion of the investigator would impair the
patients' ability to comply with the study procedures.
20. Unable to swallow study medications and comply with study
requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method